According to early research, not-yet-approved RT002 (DaxibotulinumtoxinA for Injection, Revance Therapeutics) lasts longer, might be safer and offers more dramatic wrinkle reduction than todayâs most popular neurotoxin Botox (Allergan).
Phase 2 clinical results, presented in March 2016 at the American Academy of Dermatology (AAD) annual meeting, show that three dose levels of RT002 resulted in at least 1-point improvement in frown lines based on the Investigator Global Assessment-Facial Wrinkle Severity (IGA-FWS) scale at four weeks. Revance's study also showed a six-month median duration of effect for RT002.
The effect from the mid-dose level of RT002 Injectable 40U lasted 23.6 weeks, compared to 20U of Botox lasting 18.8 weeks. An investigator assessment of none to mild wrinkles suggests RT002 Injectable 40U was superior in most cases to Botox. At six months, for example, 31 percent of subjects in the Revance group maintained no wrinkles to mild wrinkles, compared to 12 percent in the Botox arm, according to a company press release about the BELMONT phase 2 active comparator study.
Separately, independent research conducted in 2001 by Jean Carruthers, M.D., clinical professor of ophthalmology, University of British Columbia, and botulinum toxin pioneer, on Botox had shown that increased dosing does not result in meaningfully longer duration.
Safety-wise, RT002 appeared generally safe and was well-tolerated. Adverse events were predominantly localized, transient and mild, with no serious adverse events or evidence of any systemic exposure at any of the three doses evaluated, according to the release.
Revance intends to bring the RT002 40U dose to phase 3 clinical studies, expected to start after June 2016.